FDA UDI
In Commercial Distribution
🇺🇸 United States
FUSION-DOE Light System
DI: 00860179001075
·
Model: 7700512
·
Dentlight Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FUSION-DOE Light System
- Primary DI
- 00860179001075
- Version / Model
- 7700512
- Catalog Number
- 7700512
- Company Name
- Dentlight Inc.
- Labeler DUNS
- 171208585
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-09
- Public Version
- 2
- Public Version Date
- 2022-01-25
- Public Version Status
- Update
- Public Device Record Key
- c0f4946a-576c-4e2e-a867-6b1c2935c6e2
Device Description
FUSION-DOE Light System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NXV | Diagnostic Light, Soft Tissue Detector | Dental | 872.6350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60827 | Oral lesion examination light | A battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860179001075 | GS1 |
Customer Contacts
- Phone
- 8007636901
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101140 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius